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验证家用洗涤产品抗菌效果测试新方法的国际环形试验

International ring trial to validate a new method for testing the antimicrobial efficacy of domestic laundry products.

作者信息

Monleón-Getino Toni, Cavalleri Michele

机构信息

Department of Genetics, Microbiology and Statistics, Section of Statistics, University of Barcelona, Barcelona, Spain.

GRBIO, Research Group in Biostatistics and Bioinformatics, Barcelona, Spain.

出版信息

PLoS One. 2022 Jun 3;17(6):e0269556. doi: 10.1371/journal.pone.0269556. eCollection 2022.

Abstract

Due to greater environmental awareness, domestic laundry habits are changing, and antimicrobial control by chemical methods has become an essential factor to compensate for the use of lower temperatures during washing machine cycles. Disinfectants added to laundry detergents are a preventive strategy to reduce the transmission of bacteria, fungi, and viruses in the home, correct aesthetic damage (e.g., spotting, discolouration, and staining), and control the microbial contamination that leads to malodour. In Europe, disinfectants are regulated by the EU Biocidal Products Regulation (No. 528/2012), which stipulates that antimicrobial efficacy must be evaluated according to standardized methods. Current European standards for laundry sanitization only apply to clinical settings (EN 16616: 2015) and are restricted to the main wash cycle. Therefore, there is a gap in the EU standards regarding the testing of product efficacy in household laundering. With the aim of addressing this gap, an international ring trial was organized to evaluate the robustness of a new method (prEN 17658) designed to test the efficacy of antimicrobial laundry products in a domestic setting. The seven participating laboratories were equipped with 5 different laboratory-scale devices to simulate the washing process, and they evaluated 7 microbial parameters for 2 experimental conditions and 3 levels of active substance. The analysis of data according to ISO 5725-2 and ISO 13528 demonstrated that the method was robust. All reproducibility standard deviation values were between 0.00 and 1.40 and the relative standard deviation indicates satisfactory reproducibility. Values of logarithmic reduction ranged from less than 2 log10 for tests with water to more than 5 log10 when disinfectants were added. The evidence generated by the ring trial was presented in a proposal for a standardized method under CEN/TC 216, in which the SOP used in the ring trial is referred to as the prEN 17658 phase 2 step 2 test method covering chemothermal textile disinfection in domestic settings.

摘要

由于环保意识增强,家庭洗衣习惯正在改变,通过化学方法进行抗菌控制已成为弥补洗衣机洗涤周期中使用较低温度的一个重要因素。添加到洗衣粉中的消毒剂是一种预防策略,可减少家庭中细菌、真菌和病毒的传播,纠正外观损伤(如斑点、变色和染色),并控制导致恶臭的微生物污染。在欧洲,消毒剂受欧盟生物杀灭产品法规(第528/2012号)监管,该法规规定必须根据标准化方法评估抗菌效果。当前欧洲的衣物消毒标准仅适用于临床环境(EN 16616: 2015),且仅限于主洗涤周期。因此,欧盟标准在家庭洗涤产品功效测试方面存在空白。为了填补这一空白,组织了一项国际循环试验,以评估一种旨在测试家用抗菌洗衣产品功效的新方法(prEN 17658)的稳健性。七个参与实验室配备了5种不同的实验室规模设备来模拟洗涤过程,它们针对2种实验条件和3种活性物质水平评估了7个微生物参数。根据ISO 5725-2和ISO 13528对数据的分析表明该方法是稳健的。所有重现性标准偏差值在0.00至1.40之间,相对标准偏差表明重现性令人满意。对数减少值范围从用水测试时小于2 log10到添加消毒剂时大于5 log10。循环试验产生的证据在CEN/TC 216下的一项标准化方法提案中呈现,其中循环试验中使用的标准操作程序被称为prEN 17658第2阶段第2步测试方法,涵盖家庭环境中的化学热纺织品消毒。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9e2/9165900/77b86ed24098/pone.0269556.g001.jpg

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